Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection

Carcinoma Clinical Trial

— OCTSKIN  

Official title:

Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02851693
• Other study ID #: 1608069
• Secondary ID: 2016-A00647-44
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2016
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures such as biopsy or excision in order to analyze the structure and appearance of the fabric pathologists. With recent advances in optical and electronic fields, considerable efforts were produced to build high-performance optical instruments, able to transcribe the internal structure of the skin with varying degrees of depth and variable resolution.

The imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and in real time. This area is booming and new optical instruments are created to eventually be able to offer a reliable alternative to invasive techniques.

The optical properties of different tissues have been studied for several years by different research groups: the coefficient of light absorption by the tissue both in vivo and in vitro, the coefficient of light scattering or the index refractive were characterized in various tissues that make up the skin.

Other studies have focused on melanoma detection by multispectral optical techniques, or via the technique of optical coherence tomography (OCT) performed on lesions suspicious for cancer, but without linking criteria between these two techniques.

However, no study to date and to our knowledge has been able to demonstrate the different optical parameters obtained with OCT and can be directly connected to known and histopathological parameters commonly used in the diagnosis of lesions skin. This study aims to verify if it is possible to determine the parameters measured in OCT that would discriminate between benign and malignant lesions.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• patients with suspicious skin lesions of malignant tumor (mostly non-melanoma: basal cell carcinoma, epidermoid carcinoma and actinic keratoses, or melanoma: melanoma, nevi) requiring biopsy / surgical excision;

• consent signed

Exclusion Criteria:

• Any dermatosis, hyperalgesic lesion, and / or infected and / or topography making it impossible measurements;

• pregnant and nursing women

• patients under tutorship or curatorship

Related Conditions & MeSH terms

• Biopsy
• Carcinoma
• Keratosis
• Mixed Tumor, Malignant
• Resection

Intervention

Device:
• Optical Coherence Tomography (OCT) with Vivosight
OCT used is Vivosight for diagnosis
• Optical Coherence Tomography (OCT) with Skintell
OCT used is Skintell for diagnosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	National Research Agency, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite endpoint	thickness of the epidermis (µm), thickness of the dermis (µm), limit of epidermis/dermis, homogeneity of the epidermis, homogeneity and structure of the papillary dermis, vascular network associated, homogeneity of the reticular dermis, wall of vacuoles and nodules (presence or absence)	at baseline
Secondary	implementation duration	minutes	at baseline
Secondary	acquisition practices duration	minutes	at baseline
Secondary	the duration of analysis image	minutes	at baseline
Secondary	utility of labeling with a dye for histology to locate the lesion	yes or no	at baseline